The main purpose of this study is to assess how VCT220 tablets affect the bodyweight in obese or overweight adult participants. Participant will be randomly assigned to the high-dose group, low-dose group, or placebo group. Each participant will take the study drug orally once daily for 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
840
Peking University People's Hospital ( There are multiple sites in this clinical trial)
Beijing, Beijing Municipality, China
Percentage change from baseline in body weight
Time frame: From baseline to week 34
The proportion of subjects with a body weight reduction ≥5% from baseline
Time frame: From baseline to week 34
Percentage change from baseline in waist circumference
Time frame: From baseline to week 34
Percentage change from baseline in body weight
Time frame: From baseline to week 52
The proportion of subjects with a body weight reduction of ≥10%, ≥15%, and ≥20%
Time frame: From baseline to week 34 and week 52
The proportion of subjects with a body weight reduction of ≥5% from baseline
Time frame: From baseline to week 52
Percentage change from baseline in body mass index (BMI)
Time frame: From baseline to week 52
Percentage change from baseline in waist circumference
Time frame: From baseline to week 52
Percentage change from baseline in blood pressure
DBP and SBP
Time frame: From baseline to week 52
Percentage change from baseline in blood lipid profiles
TC, TG, LDL-C, and HDL-C
Time frame: From baseline to week 52
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Percentage change from baseline in fasting plasma glucose
Time frame: From baseline to week 52
Percentage change from baseline in fasting insulin
Time frame: From baseline to week 52
Percentage change from baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: From baseline to week 52
Improvement in quality of life
Measured by Impact of Weight on Quality of Life-Lite Clinical Trials questionnaire(IWQoL-Lite-CT ). The IWQoL-Lite-CT has 20 items, each scored on a 5-point Likert scale, with a total score of 100. Higher scores indicate less negative impact of weight on quality of life.
Time frame: From baseline to week 52
Improvement in quality of life
Measured by Medical Outcomes Study 36-Item Short-Form Health Survey questionnaire version 2 (SF-36 v2) . It contains 36 items grouped into 8 domains, Each item is scored based on a predefined scale. Higher scores indicate better health-related quality of life.
Time frame: From baseline to week 52